SIST EN 16224:2012+A1:2014

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zdravstvene storitve, ki jih zagotavljajo kiropraktikiBereitstellung von Gesundheitsleistungen durch ChiropraktorenPrestation de soins de santé par les chiropracteursHealthcare provision by chiropractors11.020.10Zdravstvene storitve na splošnoHealth care services in generalICS:Ta slovenski standard je istoveten z:EN 16224:2012+A1:2014SIST EN 16224:2012+A1:2014en,fr,de01-april-2014SIST EN 16224:2012+A1:2014SLOVENSKI
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SIST EN 16224:2012+A1:2014



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16224:2012+A1
January 2014 ICS 03.120.10; 11.020 Supersedes EN 16224:2012English Version
Healthcare provision by chiropractors
Prestation de soins de santé par les chiropracteurs
Bereitstellung von Gesundheitsleistungen durch Chiropraktoren This European Standard was approved by CEN on 10 May 2012 and includes Amendment 1 approved by CEN on 12 December 2013.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16224:2012+A1:2014 ESIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 2 Contents Page Foreword .5 Introduction .6 1 Scope .7 2 Terms and definitions .7 3 Service requirements . 10 3.1 Clinical practice . 10 3.1.1 Clinical records . 10 3.1.2 Case history . 10 3.1.3 Patient examination . 10 3.1.4 Further investigation / diagnostic imaging . 10 3.1.5 Clinical decision making and diagnosis . 10 3.1.6 Plan of care . 11 3.1.7 Referrals . 11 3.1.8 Use of equipment . 11 3.2 Core competencies . 11 4 Education . 13 4.1 Undergraduate chiropractic education. 13 4.2 Graduate education programme . 13 4.3 Continuing professional development . 13 5 Code of ethics . 14 6 Organisation . 14 6.1 Practical organisation of clinic facilities . 14 6.2 Facility requirements . 14 6.2.1 General . 14 6.2.2 Clinic and hygiene . 14 6.2.3 Access to the clinic . 15 6.2.4 Reception and waiting areas . 15 6.2.5 Toilet . 15 6.2.6 Consultation and treatment room . 15 6.3 Equipment requirements . 15 6.3.1 Equipment . 15 6.3.2 Maintenance . 16 6.4 Incident reporting and learning . 16 6.5 Quality assurance . 16 6.6 Insurance . 16 6.7 Professional association membership . 16 Annex A (informative)
Patient records . 17 A.1 Duty to keep patient records . 17 A.2 Content of patient records . 17 A.3 Correction of patient records . 17 Annex B (informative)
Recommended programme curriculum
.................................................................. 18 B.1 General ................................................................................................................................................. 18 B.2 Curriculum model and educational methods .................................................................................. 18 B.3 Basic biomedical sciences ................................................................................................................ 19 SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 3 B.4 Behavioural and social sciences, ethics and jurisprudence . 19 B.5 Clinical sciences and skills . 20 B.6 Clinical training . 20 B.7 Assessment methods and regulations . 21 B.8 Curriculum level, structure and composition . 21 Annex C (informative)
Code of ethics . 23 C.1 Working with patients . 23 C.1.1 Good clinical care . 23 C.1.2 Health promotion and self care . 23 C.1.3 Raising concerns about patient safety . 23 C.1.4 Equality and diversity . 24 C.1.5 Keeping up to date . 24 C.1.6 Teaching, training, appraising and assessing . 24 C.1.7 The chiropractor-patient partnership . 24 C.1.8 Communicating with patients . 24 C.1.9 Communicating with other health professionals . 25 C.1.10 Preparing reports for third parties . 25 C.1.11 Children and young people . 26 C.1.12 Vulnerable adults . 26 C.1.13 Dealing with relatives, carers and partners . 26 C.2 Openness and honesty . 26 C.2.1 General . 26 C.2.2 Maintaining trust in the profession . 27 C.2.3 Consent . 27 C.2.4 Providing access to patient health records . 28 C.2.5 Confidentiality . 28 C.2.6 Discharging patients . 28 C.3 Working with colleagues . 29 C.3.1 General . 29 C.3.2 Colleagues’ conduct and performance . 29 C.3.3 Respect for colleagues . 29 C.3.4 Sharing information with colleagues . 29 C.3.5 Delegation and referral . 29 C.3.6 Honesty and trustworthiness . 30 C.3.7 Providing and publishing information about chiropractic services . 30 C.3.8 Writing reports and giving evidence . 30 C.3.9 Research. 30 C.3.10 Financial dealings . 31 C.3.11 Conflicts of interest . 31 SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 4 C.4 Health and safety . 31 C.4.1 General . 31 C.4.2 Evidence-based care . 31 !Annex D (informative)
A-deviations" . 32 Bibliography . 35
SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 5 Foreword This document (EN 16224:2012+A1:2014) has been prepared by Technical Committee CEN/TC 394 “Project Committee - Services of chiropractors”, the secretariat of which is held by ASI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 2014, and conflicting national standards shall be withdrawn at the latest by July 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 16224:2012. This document includes Amendment 1 approved by CEN on 12 December 2013. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 6 Introduction The World Health Organization (WHO) defines chiropractic as a primary contact healthcare profession concerned with disorders of the neuromusculoskeletal system, particularly the spine, and the effect of these disorders on the function of the nervous system and on general health. Treatment encompasses a wide range of interventions, but emphasis is placed on manual methods of care. The chiropractic profession has evolved in Europe and occupies an important position in both primary and secondary healthcare provision. It is therefore imperative that chiropractic services are delivered at the highest attainable level. The principal objective of any standard for healthcare services ought to be that users of any given service can be confident of a level of care that assures reproducible quality throughout the profession. Clinical governance, the determination of monitoring healthcare provision and ensuring maintenance of standards therefore form one of the cornerstones of care. This standard is concerned with the provision of chiropractic services. It aspires to set a standard that provides optimum levels of patient management, patient safety, clinical and cost effectiveness and ethical practice. It also defines a level of education consistent with producing chiropractors who are competent to comply with the standard. It is not intended to be a guideline, although information contained might inform the development of guidelines for individual nations and national organisations. Finally, this standard encourages that services provided by chiropractors be subjected to regular review through an evidence-based approach and a commitment to supporting and acting upon clinical research. This European Standard does not supersede national legislation. SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 7 1 Scope This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 assessment health professional’s evaluation of a disease or condition based on the patient’s subjective report of the symptoms and course of the illness or condition, along with the objective findings including examination, laboratory tests, diagnostic imaging, medical history and information reported by family members and other health professionals 2.2 audit review and assessment of healthcare procedures and documentation for the purposes of comparing the quality of care provided with accepted standards 2.3 biopsychosocial model model that refers to the interactions between biological, psychological and sociological factors 2.4 capacity ability of a patient to understand, remember and consider information provided to them 2.5 care interventions that are designed to improve health 2.6 case history detailed account of a person’s history which results from the acquisition of information through interview, questionnaires and assessment of appropriate medical records 2.7 chaperone person who is present during a professional encounter between an health professional and a patient EXAMPLE Family members or another member of the healthcare team. 2.8 chiropractic health profession concerned with the diagnosis, treatment and prevention of mechanical disorders of the musculoskeletal system, and the effects of these disorders on the function of the nervous system and general health Note 1 to entry: There is an emphasis on manual treatments including spinal adjustment and other joint and soft-tissue manipulation. Note 2 to entry: Taken from WFC Dictionary definition [11]. SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 8 2.9 chiropractic institution educational establishment dedicated to the provision of chiropractic education and training 2.10 clinical guidelines systematically developed statements designed to assist both practitioner and patient decisions about the appropriate healthcare for specific clinical circumstances 2.11 clinical record document which relates to the diagnosis, assessment and care of a patient 2.12 consent acceptance by a patient of a proposed clinical intervention after having been informed of all relevant factors relating to that intervention 2.13 continuing professional development CPD means by which members of a profession maintain, improve and broaden their knowledge and skills and develop the personal qualities required in their professional lives 2.14 delegation asking someone who is not a regulated health professional to provide care on a chiropractor’s behalf 2.15 diagnosis identification of a disease or illness resulting from clinical assessment 2.16 diagnostic procedure structured procedure that exists to enable a chiropractor to arrive at a diagnosis which may include physical examination, diagnostic imaging and laboratory tests 2.17 discharge release of a patient from a course or programme of care 2.18 evidence-based care clinical practice that incorporates the best available evidence from research, the expertise of the practitioner, and the preference of the patient 2.19 formal education educational activity at established recognised formal systems of elementary, secondary or higher education Note 1 to entry: Compare with the ISO 29990:2010, definition 2.15 "non-formal education" [4]. 2.20 further investigation additional clinical study which contributes to the assessment of a patient and which may include diagnostic imaging and laboratory tests SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 9 2.21 graduate education programme GEP dedicated framework for the continuing education of new graduates of chiropractic institutions during their initial period in practice 2.22 health state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity Note 1 to entry: Specified in the preamble to the "Constitution of the World Health Organization" [6]. 2.23 health promotion provision of information on healthier lifestyles for patients, and how to make the best use of health services, with the intention of enabling people to make rational health choices and of ensuring awareness of the factors determining the health of the community 2.24 medical device instrument, apparatus, appliance, material or other article, either used alone or in combination, including the software necessary for its proper application and intended by the manufacturer to be used for human beings Note 1 to entry: This definition is in accordance with Council Directive 93/42/EEC [7] and with EN ISO 13485:2003 [1]. 2.25 neuromusculoskeletal interaction between the nervous system, musculature and skeletal framework of the body 2.26 patient confidentiality right of an individual to have information about them kept private 2.27 patient examination assessment of a patient with the intention of reaching or reviewing a diagnosis or plan of care 2.28 plan of care plan designed to deliver therapeutic benefit to patients following diagnosis 2.29 primary contact practitioner healthcare professional qualified to undertake a process of assessment, diagnosis and care in the absence of a formal referral from another registered healthcare provider 2.30 professional development continuum of education, embracing undergraduate and postgraduate studies and regular refresher training 2.31 referral transferring of responsibility for care to a third party for a particular purpose, such as additional investigation, care or treatment that is outside the chiropractor’s competence 2.32 undergraduate chiropractic education acquisition of knowledge and skills by students at chiropractic institutions leading to an accredited qualification in chiropractic SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 10 3 Service requirements 3.1 Clinical practice 3.1.1 Clinical records Clinical records shall be maintained in accordance with good professional conduct and shall contain relevant and necessary information about the patient and the patient's healthcare (see also Annex A). 3.1.2 Case history The chiropractor shall acquire and document current and past information on a patient related to their health (i.e. physical, psychological and social wellbeing) by asking specific questions, either of the patient, responsible adult or legal guardian with the aim of obtaining suitable clinical information useful in formulating a diagnosis and leading to a plan of care for the patient. 3.1.3 Patient examination a) Following the taking of the case history, the patient shall be investigated for signs of disease, abnormality or dysfunction. b) The chiropractor shall use examination methods that include, but are not limited to, physical examination procedures; orthopaedic, neurological, and chiropractic tests, as clinically indicated. 3.1.4 Further investigation / diagnostic imaging The chiropractor shall: a)
identify when further investigations are needed and act on this need in the patient’s best interests; b) use further investigations when the information gained from such investigations will benefit the management of the patient; c) undertake and/or interpret the results or, if this is not possible, refer the patient for appropriate further investigations; d) record the outcomes of the investigations in the patient record. 3.1.5 Clinical decision making and diagnosis The chiropractor shall: a) evaluate the patient’s health status and health needs from the information gained during the case history, physical examination and further investigations; b) formulate and document a working diagnosis and/or differential diagnosis and a rationale for care, based on the evaluation of this information. The diagnosis, or rationale for care, shall be kept under review while caring for the patient; c) interpret all of the information available about a patient and then make and record decisions about the patient’s health and health needs and how these change over time; d) consider the natural history and prognosis of any presenting complaint, or emergency situation that might need immediate action, and the likelihood of preventing recurrences or managing any long-term healthcare needs. SIST EN 16224:2012+A1:2014



EN 16224:2012+A1:2014 (E) 11 3.1.6 Plan of care The chiropractor shall: a) develop and record an agreed plan of care, taking into account the wishes and preferences of the patient. The plan of care should encourage the patient to participate in improving their own health. The plan of care shall have specified aims and be consistent, appropriate and safe with the patient’s identified health and health needs; b) be knowledgeable about the underlying theories of the care they provide and be competent to apply that form of care in practice. The chiropractors’ provision of care shall be evidence-based. The patient shall have given informed consent to the form of care provided; c) review with patients the effectiveness of the plan of care in meeting its agreed aims. 3.1.7 Referrals The chiropractor shall consider onward referral to another appropriately qualified healthcare professional when it becomes clear that a patient a) is not appropriate for chiropractic care, or b) requires concurrent or additional investigation or care, or c) is failing to respond to chiropractic care, is deteriorating or has developed additional symptoms outside the field of expertise of the chiropractor. Referrals should be in writing or done verbally and should detail the reason for the referral, the care provided by the chiropractor and any relevant aspects of the patient’s health. Referral details shall be noted in the patient record. 3.1.8 Use of equipment All medical devices used by chiropractors shall be CE-marked [7]. In case of X-ray equipment, management shall fulfil Council Directive 96/29/Euratom [8]. A maintenance record shall be kept for each piece of equipment or device. 3.2 Core competencies a) The chiropractor shall have knowledge and understanding of: 1) normal structure and function of the human body; 2) aetiology, pathology, symptoms and signs, natural history and prognosis of neuromusculoskeletal complaints, pain syndromes and associated conditions presenting to chiropractors, including the psychological and social aspects of these conditions; 3) evaluation of the health and health needs of a patient, including common diagnostic procedures, their uses and limitations, and appropriate referral procedures; 4) management of neuromusculoskeletal conditions using manual therapies, physical rehabilitation, general nutritional advice, and the principles of health promotion and disease prevention; 5) scientific methods to provide and understand the evidence-base for current chiropractic practice, an
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